Official Title
Coronavirus Disease 2019 (COVID-19) During Pregnancy: Prevalence of Seroconversion, Effect on Maternal and Perinatal Outcomes and Risk of Vertical Transmission (COVID-MAP)
Brief Summary

The objectives of this proposal are to: 1) determine the rate of SARS-CoV-2seroconversion in unselected pregnant women in Hong Kong; 2) determine the rate ofSARS-CoV-2 infection in women presenting with miscarriage and stillbirth; 3) follow thepregnancy course and perinatal outcome of confirmed COVID-19-infected pregnant cases; 4)determine the risk and characteristics of vertical transmission; and 5) evaluate theplacental barrier, immune response and fetal damage in vertical transmission ofSARS-CoV-2. A series of longitudinal and cross-sectional observational studies, and alaboratory-based study will be conducted to fulfil the 5 objectives.

Detailed Description

With over 10 million individuals infected worldwide, the coronavirus disease 2019
(COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2),
is a global public health crisis. It is recognized that pregnant women are at an
increased risk of acquiring viral respiratory infection and developing severe pneumonia
due to the physiologic changes in their immune and cardiopulmonary systems. Previous
studies have attempted to determine maternal and perinatal outcome and potential risk of
vertical transmission in pregnant women affected by COVID-19, however, relevant clinical
data and biological samples have not been collected in a systematic manner. The research
project will engage in collaborative research across obstetricians/maternal-fetal
medicine subspecialists, gynecologist, infectious disease specialists, pediatrician,
developmental and molecular biologists and bioinformatician between the CUHK, China and
Spain. The objectives of this proposal are to: 1) determine the rate of SARS-CoV-2
seroconversion in unselected pregnant women in Hong Kong; 2) determine the rate of
SARS-CoV-2 infection in women presenting with miscarriage and stillbirth; 3) follow the
pregnancy course and perinatal outcome of confirmed COVID-19-infected pregnant cases; 4)
determine the risk and characteristics of vertical transmission; and 5) evaluate the
placental barrier, immune response and fetal damage in vertical transmission of
SARS-CoV-2. A series of longitudinal and cross-sectional observational studies, and a
laboratory-based study will be conducted to fulfil the 5 objectives.

Results generated will inform obstetrics and gynecology, pediatric and infectious disease
scientific communities as well as public health specialists and policy makers regarding:
(1) the estimated seroconversion rate in women of childbearing age; these results will
help (i) improve the approach to care for pregnancy and childbirth during the COVID-19
outbreak; and (ii) formulate preventive measures to be implemented specifically for
pregnant women in reducing risk of infection and associated complications to both the
women and their unborn child; (2) the impact of COVID-19 on maternal and perinatal
outcomes; data from high-quality research will inform practice during the COVID-19
outbreak, guiding healthcare professionals on how to adjust the management approach to
infected pregnant women and the exact risks the infection poses to the babies; (3) the
risk of vertical transmission at different stages of pregnancy and its sequelae; findings
of this study will guide counselling, decision making and clinical management; (4) the
identification of cellular site of viral entry and replication in the maternal-fetal
interface that would be instrumental in designing therapeutic measures to cease vertical
transmission and developing therapeutic treatments.

Recruiting
COVID-19

Other: Non Intervention

It's an observational study, no intervention involves.

Eligibility Criteria

Objective 1: Seroconversion during pregnancy

Inclusion criteria:

- Pregnant women who attended for Down syndrome screening (DSS) at 11-13 weeks

- Had serum sample taken between 1 November 2019 and 1 June 2020 consented for stored
serum for future research

- Intended to deliver at the booking hospital.

Objective 2: SARS-CoV-2 and pregnancy loss

Inclusion criteria:

•Pregnant women presenting with first and second trimester miscarriage in Hong Kong and
Spain, as well as those with stillbirth during periods of 6 and 12 months, respectively.

Objective 3: Pregnancy course and perinatal outcome

Inclusion criteria:

•Pregnant women affected by COVID-19

Objective 4: Vertical transmission

Inclusion criteria:

•Pregnant women affected by COVID-19

Objective 5: Potential mechanisms for vertical transmission

Inclusion criteria:

•Pregnant women affected by COVID-19

Eligibility Gender
Female
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
China
Hong Kong
Spain
Locations

Peking University First Hospital
Beijing, Beijing, China

Kwong Wah Hospital
Hong Kong, Hong Kong

Pamela Youde Nethersole Eastern Hospital
Hong Kong, Hong Kong

Princess Margaret Hospital
Hong Kong, Hong Kong

Queen Elizabeth Hospital
Hong Kong, Hong Kong

Queen Mary Hospital
Hong Kong, Hong Kong

The Chinese University of Hong Kong, Prince of Wales Hospital
Hong Kong, Hong Kong

Tuen Mun Hospital
Hong Kong, Hong Kong

United Christian Hospital
Hong Kong, Hong Kong

Hospital Universitario de Torrejón
Torrejón De Ardoz, Madrid, Spain

Contacts

Liona POON
(852) 3505 2582
liona.poon@cuhk.edu.hk

Equal CHEN
(852) 3505 1536
equalchen@cuhk.edu.hk

Chinese University of Hong Kong
NCT Number
Keywords
pregnancy
Vertical transmission
pregnancy loss
ACE2 TMPRSS2
MeSH Terms
COVID-19